The effectiveness of smartphone app guided interval-walking training compared to continuous aerobic walking training for people with type 2 diabetes or prediabetes. A pilot study.

Not Applicable

Recruiting

• Conditions: Type 2 diabetes, prediabetes; E11; Type 2 diabetes mellitus

• Registration Number: DRKS00016370
• Lead Sponsor: Gesundheitspraxis Löwen Center AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Participants fulfilling all of the following inclusion criteria are eligible for the study:

• Informed Consent as documented by signature
?
• Individuals with type 2 diabetes or prediabetes diagnosed by a GP

• Ability to walk 30 min continuously?

• Ability to read and speak German ?fluently

• No contraindication, which prohibit physical activity

• Owning a smartphone (Apple / Android)

Exclusion Criteria

The presence of any one of the following exclusion criteria will lead to exclusion of the participant: ?

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

• Patients receiving long-term insulin and/or sulfonylurea treatment

• Contraindication, which prohibit physical activity (e.g. uncontrolled arterial hypertension, limited cardiac insufficiency)

• Limiting musculoskeletal disorders, which prohibit the participation (Injury in lower limbs, painful osteoarthritis etc.)

• No informed consent

• <18 years of age

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this pilot study is to assess the feasibility of the study design that is key to the success of a large-scale study.<br>The feasibility factors of the study design are measured by reasons for exclusion, recruitment rate, reasons for dropouts, patients’ satisfaction, intensity of the training method, missing data, estimated sample size. The feasibility factors will be measured during the whole study time and are assessed by descriptive statistics, questionnaires and interviews. <br>

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is a comparison between the effects of a smartphone app guided outdoor interval walking-training and a continuous aerobic walking-training in terms of anthropometric measurements (WtHR, weight), aerobic capacity (6-MWT) and improvements in quality of life (SF-36) in patients with type 2 diabetes or prediabetes. These measurements will take place at baseline and after 4 weeks of training.